FDA accepts New Drug Application for loteprednol etabonate gel

The U.S. Food and Drug Administration (FDA) accepted the New Drug Application for a submicron formulation of loteprednol etabonate ophthalmic gel 0.38% (Bausch + Lomb, Bridgewater, New Jersey), according to a company press release. The Prescription Drug User Fee Act action date for the agent is Feb. 25, 2019. If approved, the agent would be the lowest concentrated loteprednol ophthalmic corticosteroid indicated to treat postop inflammation and pain after ocular surgery, according to the press release. The submicron particle in the product helps to increase ocular penetration and residence time in anterior segment tissues.

U.S. FTC gives clearance for Takeda acquisition of Shire

The U.S. Federal Trade Commission (FTC) has given unconditional clearance for the proposed acquisition of Shire (Dublin, Ireland) by Takeda Pharmaceuticals (Osaka, Japan). The acquisition is still subject to several conditions, including other regulatory clearances and approval by shareholders from both companies, according to a news release. It will be the biggest acquisition by a Japanese company of a Western company and will create the world's eighth-largest drug maker by sales, according to an article from earlier this year in the Wall Street Journal. The transaction is expected to close in the first half of 2019.

Physician burnout leads to more medical errors

Physician burnout and fatigue were independently associated with major medical errors, according to Daniel Tawfik, MD, and coresearchers in their population-based survey of U.S. physicians. Among 6,5866 physicians in active practice, 54.3% reported symptoms of burnout. Nearly 33% reported excessive fatigue, and 6.5% reported suicide ideation. Nearly 4% had a poor or failing patient safety grade in their primary work area; 10.5% reported a major medical error in the prior 3 months. Physicians reporting errors were more likely to have burnout symptoms, fatigue, and recent suicide ideation in the study. Interventions to decrease medical errors should address both physician well being and work unit safety, the authors concluded. The study appears in Mayo Clinic Proceedings.

Medical software applications for AMD receives FDA 510(k) clearance

A mobile medical software application to detect and monitor age-related macular degeneration received FDA 510(k) clearance this week. Alleye (Oculocare medical, Zurich, Switzerland) is designed to detect and characterize central and paracentral metamorphopsia in patients with macular conditions, according to a company press release. After an eye specialist diagnoses macular disease, patients can use Alleye to perform self-tests at home to monitor their eyesight or assess disease progression.

RESEARCH BRIEFS

Disease progression was stopped by the use of corneal collagen crosslinking (CXL) using Dresden or accelerated protocols to treat keratoconus with Scheimpflug tomography, according to Mehdi Shajari, MD, and coresearchers. They studied 58 eyes with manifest keratoconus that was measured preop at least twice with the Pentacam (Oculus, Wetzlar, Germany). A difference of relevant variables for keratoconus progression was established. After obvious progression, patients had CXL (29 eyes with the Dresden protocol and 29 with the accelerated protocol). Variables to define manifest progression were again compared. The mean D value was 9.6 for the Dresden cohort and 8.3 for the accelerated cohort. There was no significant preop difference between both cohorts for the D value, but there was a significant difference postop (Dresden: -0.47 versus 0.04 for accelerated). Keratoconus progression was significant in both groups before surgery; postop data showed an improvement in all observed keratoconus indices in both study groups and stagnation in progression for the accelerated cohort for the D value and a regression in manifestation for the Dresden cohort. The research is published in Cornea.

There was more acute postop endophthalmitis after combined cataract surgery compared with cataract surgery done as a standalone procedure, according to a study by Catherine Creuzot-Garcher and coresearchers. They focused on the incidence of acute postop endophthalmitis after cataract surgery combined with corneal, glaucoma, or vitreoretinal surgical procedures from 2005 to 2014 in France. Acute postop endophthalmitis was detected using billing codes recorded in a national database. In that time period, 6.26 million eyes had phacoemulsification as a standalone procedure, and 115,468 had phaco combined with corneal, glaucoma, or vitreoretinal surgical procedures. The crude incidence of acute postop endophthalmitis after standalone or combined cataract surgery was 0.102% and 0.149%, respectively. With a multivariate Poisson analysis, combined surgery was at higher risk than standalone cataract surgery, with an adjusted incidence rate ratio of 1.38 (1.11 to 1.70,P=0.054). The incidence of endophthalmitis was lower with glaucoma surgeries compared with vitreoretinal surgical procedures. The study is published in the British Journal of Ophthalmology.

A trifocal IOL with a low IOL power (0.0 to 10.0 D) in highly myopic eyes provided good short-term visual and refractive outcome. However, the results were not as good as those in eyes with a higher dioptric IOL power, according to Gernot Steinwender, MD, and coresearchers. Their study included eyes with prior phaco and implantation of the AT LISA tri 839MP or 939MP (Carl Zeiss Meditec, Jena, Germany). Postop outcomes at 3 months included uncorrected distance visual acuity (UDVA), intermediate (UIVA) and near visual acuity (UNVA), corrected distance visual acuity, spherical equivalent, and refractive astigmatism. Age-matched eyes after implantation of the same trifocal IOL with a higher dioptric power (>10 D) served as controls. There were 36 eyes from 19 patients (18 eyes in each group). At 3 months, the mean UDVA, UIVA, and UNVA in the highly myopic group were 0.06 logMAR, 0.13, and 0.12, respectively, compared with -0.01, 0.04, and 0.04 in the control group. The study is published in the Journal of Cataract & Refractive Surgery.

Myopia among Chinese students is the highest of any cultural or ethnic group, according to Sean Wang, BS, and coresearchers. Their observational study had a cohort from 19 primary schools and 22 junior high schools, all located in Guangzhou, China. Myopia was defined as a spherical equivalent refraction of -0.50 D or less, as measured by subjective refraction without cycloplegia. High myopia was defined as a spherical equivalent refraction of -6.0 D or less. There was a total of 4,741 students with or without myopia among the grade 1 and grade 7 cohorts. The baseline mean spherical equivalent refraction was 0.31 D among 1,975 students in grade 1 compared with -1.60 D among 2,670 students in grade 7. The baseline prevalence of myopia was 12% in grade 1 and 67.4% in grade 7. The incidence of high myopia was initially less than 1% in the primary school cohort, but the incidence exceeded 2% in the junior high cohort. Myopia incidence was 20% to 30% each year throughout both cohorts. If these results are confirmed with cycloplegic refraction, interventions to prevent myopia onset in the Chinese population should be initiated in primary schools, the authors concluded. The study appears in JAMA Ophthalmology.

This issue of EyeWorld Weekly Update was edited by Amy Goldenberg and Vanessa Caceres.

EyeWorld Weekly Update (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Administrators, is published every Friday, distributed by email, and posted live on Friday.